August 4, 2020
By Debby Newslow President/Owner/Consultant/Auditor/Trainer/Speaker/Author at D L Newslow & Associates, and Sarah Beale, Staff Writer, MasterControl
Companies that were prepared with good quality management have fared better during the pandemic. ISO 9001 in particular has proved inadvertently helpful in adapting to disruption. To see how ISO connects to COVID-19, we spoke to Debby Newslow of D.L. Newslow & Associates.
July 30, 2020
By James Jardine, Staff Writer, MasterControl
Whether you like it or not, you should brace yourself for Industry 5.0. The term refers to people working alongside robots and smart machines. If that definition brought to mind the image of Will Smith battling evil robots in the movie “I, Robot,” here are a few things you need to know about Industry 5.0.
July 28, 2020
By David Butcher, Staff Writer, MasterControl
The pandemic has highlighted the need for a faster, more flexible and scalable manufacturing environment that balances speed with compliance. While paper-based processes can slow production down or jeopardize quality, paperless production processes can streamline operations, reduce errors and readily leverage data critical to ensuring quality. A configurable, purpose-built electronic device history record (eDHR) application can be fast to implement and deliver quantifiable benefits.
July 27, 2020
By David Butcher, Staff Writer, MasterControl
A digital gap remains between quality assurance and manufacturing operations, as people on the production line still rely on paper-based production records and spreadsheets. This gap has left manufacturers susceptible to data entry errors, long good quality review times, shipment delays and other paper-based challenges. A paperless approach can deliver measurable results that have a notable impact on manufacturing operations, product quality and the bottom line.
July 27, 2020
By Sarah Beale, Staff Writer, MasterControl
How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).
July 24, 2020
By David Butcher, Staff Writer, MasterControl
The global COVID-19 pandemic has forced many manufacturers to re-examine how they manage their supply chains. Amid large-scale shocks to supply and demand, manufacturers and their supplier partners must balance speed with quality, without putting their own employees at risk or adding significant costs. Now is the time to. Leveraging digital supplier management tools can help manufacturers streamline supplier processes like audits and inspections without the on-site threat to employees and vendors and unnecessary travel costs.
July 17, 2020
By Jason Orloff, Statistical & Engineering Consultant, Pharmstat
The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).
July 17, 2020
By Belinda Dowsett, Quality Assurance Manager and Consultant, and Brandwood CKC
So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.
July 16, 2020
by Sarah Beale, Staff Writer, MasterControl
MasterControl Product Management Director Sue Marchant sat down with GxP Lifeline to talk about our platform approach, why that’s important and how it can eventually lead to artificial intelligence (AI) applications for our customers. She also gave us a sneak peek at what to expect in the next generation of MasterControl products.
July 15, 2020
By David Butcher, Staff Writer, MasterControl
Nelson Laboratories, a global provider of microbiological and analytical laboratory testing, is one of the many companies making an impact in the protective barriers area during the pandemic. The Salt Lake City-based company is heavily involved in testing the efficacy of facemasks and respirators. In a recent interview, Nelson Labs President Jeffrey R. Nelson spoke on what it has taken to achieve 24/7 coverage while maintaining quality and protecting employee health.
July 13, 2020
By Sue Spenser, Head of IVD and Principal Consultant, Qserve
If you are preparing to implement IVDR, there are specific gaps that are easily missed. Ensure the intended purpose is clear, risk management issues have been addressed, and pay close attention to details.
July 10, 2020
By Dale Thompson, Staff Writer, MasterControl
Manufacturing batch record trends from 2019 have picked up speed in 2020. Now is the time to focus on becoming data-centric, move to digital batch records, utilize the potential of workers on the shop floor, and create a truly paperless manufacturing environment.
July 9, 2020
By Sarah Beale, Staff Writer, MasterControl
Cannabis is legally and socially becoming more accepted worldwide. New regulations, new products and new technology are all helping the cannabis industry mature. In 2020, these trends are expected to shape the industry.
July 8, 2020
By Sarah Beale, Staff Writer, MasterControl
Five major trends hit nutraceuticals last year. For the most part, those trends played out as expected. What was not expected was for the year to end in the COVID-19 pandemic. We’d like to take a look at how the pandemic has changed last year’s trends and what the future likely holds for the nutraceutical industry.
July 7, 2020
By James Jardine, Staff Writer, MasterControl
As companies grow more reliant on geographically dispersed contractors, partners, vendors and business units, it gets harder to align quality across all the entities involved. Learn how global companies like Fagron maintain quality consistency across multiple sites and discover why connecting data and processes within a robust digital platform is the surest way to align quality across your entire ecosystem.
July 2, 2020
By Derek Churchill, and David Jensen, Staff Writer, MasterControl
The COVID-19 pandemic disrupted many aspects of global societies, lifestyles and economies. Fortunately, technology has enabled the regulatory industry to continue functioning by conducting audits remotely. In this article, Derek Churchill, senior consultant at Quality Support Group (QSG), explains how remote audits work and how companies can prepare for this new type of audit.
June 30, 2020
By Susan Schniepp, Distiguished Fellow at Regulatory Compliance Associates, Inc
Data integrity is a high priority to both the pharmaceutical industry and regulatory authorities. To improve data integrity, it's critical to example the role of quality in your company culture.
June 26, 2020
By David Jensen, Staff Writer, MasterControl
Regulated companies are often reminded that if it isn’t documented, it didn’t happen. It’s also safe to say if it is documented, but the documents can’t be found, it didn’t happen. An efficient document control system is at the core of quality management and good manufacturing practices.
June 23, 2020
By Lynessa Erler, Director of Product Testing at MPR Associates, Inc.
Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.
